MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER

K073423 · C.R. Bard, Inc. · LJT · Dec 19, 2007 · General Hospital

Device Facts

• Record ID: K073423
• Device Name: MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER
• Applicant: C.R. Bard, Inc.
• Product Code: LJT · General Hospital
• Decision Date: Dec 19, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5965
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PowerPort™ devices are totally implanted vascular access devices designed to provide long-term, repeated access to the vascular system.

Device Story

Totally implanted vascular access device; consists of plastic port and 9.6 Fr silicone catheter; attached via cathlock compression fitting. Distinguishable by triangular body, purple coloring, and three palpation bumps on septum. Used in clinical settings by healthcare professionals for long-term, repeated vascular access. Routine access via non-coring needle; power injection requires use of Bard PowerLoc™ safety infusion set. Enables infusion of medications, fluids, nutrition, blood products, and blood sampling. Power injection capability allows contrast media delivery for imaging procedures. Benefits patient by providing reliable, repeated access while minimizing need for frequent venipuncture.

Clinical Evidence

Bench testing only. Design verification testing performed per FDA guidance and recognized international standards. Risk management conducted via FMEA per ISO 14971:2000. No new safety or efficacy questions identified.

Technological Characteristics

Plastic port with 9.6 Fr silicone catheter; cathlock compression fitting. Triangular body, purple color, three septum palpation bumps. Designed for power injection (max 5 ml/s) when used with PowerLoc™ safety infusion set. Sterilization method not specified.

Indications for Use

Indicated for patients requiring repeated vascular access for infusion of medication, I.V. fluids, parenteral nutrition, blood products, and blood withdrawal. When used with a PowerLoc™ safety infusion set, indicated for power injection of contrast media at a maximum rate of 5 ml/s.

Regulatory Classification

Identification

A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.

Predicate Devices

• MRI PowerPort™ Polymeric Implanted Port with 8 Fr. ChronoFlex® Polyurethane Catheter (K063377)
• Hickman™ Plastic Subcutaneous Port (K873213)

Submission Summary (Full Text)

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| General<br>Provisions | Submitter Name:<br>Address:<br>Telephone Number:<br>Fax Number:<br>Contact Person:<br>Date of Preparation:<br>Registration Number: | Bard Access Systems, Inc. (BAS)<br>[Wholly owned subsidiary of C.R. Bard, Inc.]<br>605 N 5600 W<br>Salt Lake City, UT 84116<br>[phone] ext. 5484<br>[phone]<br>Susan Scott<br>December 3, 2007<br>1720496 BAS<br>2212754 C. R. Bard<br>DEC 1 9 2007 |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject<br>Device | Trade Name:<br>Common/Usual Name:<br>Classification Name: | MRI PowerPort™ Implanted Port<br>with 9.6 Fr Silicone Catheter<br>Implanted Infusion Port & Catheter<br>80 LJT - Subcutaneous, Implanted, Intravascular<br>Infusion Port & Catheter |
| Predicate<br>Devices | Trade Name:<br>Common/Usual Name:<br>Classification Name:<br>Premarket Notification:<br>Trade Name:<br>Common/Usual Name:<br>Classification Name:<br>Premarket Notification: | MRI PowerPort™ Polymeric Implanted Port<br>with 8 Fr. ChronoFlex® Polyurethane Catheter<br>Implanted Infusion Port & Catheter<br>80 LJT - Subcutaneous, Implanted, Intravascular<br>Infusion Port & Catheter<br>K063377, clearance date Jan 25, 2007<br>Hickman™ Plastic Subcutaneous Port<br>Implanted Infusion Port & Catheter<br>80 LJT - Subcutaneous, Implanted, Intravascular<br>Infusion Port & Catheter<br>K873213, clearance date Oct. 27, 1987 |
| Classification | Class II<br>21 CFR §880.5965<br>General Hospital | |
| Performance<br>Standards | Performance standards have not been established by FDA under section 514<br>of the Federal Food, Drug and Cosmetic Act. | |
| Intended Use | PowerPort™ devices are totally implanted vascular access devices designed<br>to provide long-term, repeated access to the vascular system. | |
| Indications<br>for Use | The PowerPort™ implanted port is indicated for patient therapies requiring<br>repeated access to the vascular system. The port system can be used for<br>infusion of medication, I.V. fluids, parenteral nutrition solutions, blood<br>products, and for the withdrawal of blood samples.<br>When used with a PowerLoc™ safety infusion set, the PowerPort™ device is<br>indicated for power injection of contrast media. For power injection of<br>contrast media, the maximum recommended infusion rate is 5 ml/s. | |
| Device<br>Description | The subject MRI PowerPort™ device with 9.6 Fr silicone catheter is a<br>member of the PowerPort™ series of power injectable implanted ports. The<br>subject device consists of a plastic port and silicone catheter that is attached<br>to the port with a cathlock compression fitting. The subject device is<br>distinguishable as a member of BAS's power injectable port series by the<br>triangular body shape, unique purple coloring, and three palpation bumps on<br>the septum.<br>PowerPort™ implanted ports can be used for routine vascular access using a<br>non-coring access needle. However, for power injection procedures,<br>PowerPort™ ports must be accessed with a Bard PowerLoc™ safety infusion<br>set to create a power injectable system. | |
| Technological<br>Characteristics | Technological characteristics of the subject MRI PowerPort™ device with 9.6<br>Fr silicone catheter are equivalent to those of the Bard Access Systems<br>predicate MRI PowerPort™ device [K063377]. This equivalence extends to<br>port's basic design, generic materials, and construction. The distinguishing<br>difference exists in the size and material of the subject catheter. | |
| Safety &<br>Performance<br>Tests | No performance standards have been established under Section 514 of the<br>Food, Drug and Cosmetic Act for this device. However, design verification<br>testing was performed according to protocols based on the<br>recommendations/requirements of applicable FDA guidance and FDA<br>recognized international standards. Verification testing, determined to be<br>applicable to the safety and efficacy of the device, was shown to meet<br>predetermined acceptance criteria listed therein.<br>Risk management, including a failure modes and effects analysis (FMEA), of<br>the subject device was conducted in accordance with an internal protocol<br>based on ISO 14971:2000, Medical Devices - Risk Management for Medical<br>Devices. The analysis did not identify any new types of safety or efficacy<br>questions for the subject MRI PowerPort™ device with 9.6 Fr silicone<br>catheter. | |
| Summary of<br>Substantial<br>Equivalence | Based on the indications for use, technological characteristics, and safety and<br>performance testing, the subject MRI PowerPort™ device with 9.6 Fr silicone<br>catheter meets the minimum requirements that are considered adequate for<br>its intended use and is substantially equivalent in design, materials,<br>sterilization, principles of operation and indications for use to current<br>commercially available implanted ports cited as predicates. | |

## 510(k) Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2007

Ms. Susan D. Scott Regulatory Affairs Specialist C.R. Bard, Incorporated Bard Access Systems 605 North 5600 West Salt Lake City, Utah 84116

Re: K073423

Trade/Device Name: MRI PowerPort™ Implanted Port with 9.6 Fr Silicone Catheter Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: December 3, 2007 Received: December 5, 2007

Dear Ms. Scott:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Scott

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4 - Indications for Use Statement

## Indications for Use Statement

510(k) Number (if known):

K073423

Device Name:

MRI PowerPort™ Implanted Port with 9.6 Fr Silicone Catheter

Indications for Use:

The PowerPort™ implanted port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medication, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a PowerLoc™ safety infusion set, the PowerPort™ device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s.

Prescription Use _ V Over-The-Counter Use AND/OR (21 CFR §801 Subpart C) (Part 21 CFR §801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Arten D. m

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: